Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Metformin & Secretagogues
Drug: Technosphere Insulin
Drug: Technosphere Insulin & Metformin

Registration Number: NCT00332488

Lead Sponsor: Mannkind Corporation

Brief Summary: to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 547

Inclusion Criteria

Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months
Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
HbA1c >or= to 7.5% and < or= to 11.0%
BMI < or = to 40kg/m2.
FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

Exclusion Criteria

Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks
Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects
History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Metformin & Secretagogues	Metformin \& Secretagogues
1	Technosphere Insulin	Technosphere Insulin
3	Technosphere Insulin & Metformin	Technosphere \& Metformin

Primary Outcome Measures

Name	Time	Method
Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue	Baseline to Week 12	(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)
Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)	Week 24

Trial Locations

Locations (118): Washington University School of Medicine
🇺🇸
St. Louis, Missouri, United States
International Clinical Research Network
🇺🇸
Chula Vista, California, United States
James A Dicke MDPA
🇺🇸
Towson, Maryland, United States
North Shore Diabetes and Endocrine Associates
🇺🇸
New Hyde Park, New York, United States
Dayton Clinical Research
🇺🇸
Dayton, Ohio, United States
Baylor Endocrine Center
🇺🇸
Dallas, Texas, United States
Instituto de Pesquisa Clinica e Medicina Avancada
🇧🇷
Sao Paulo, Brazil
Unimedico Management
🇨🇦
Richmond Hill, Canada
Centro de Estudios en Diabetes
🇲🇽
Mexico City, Mexico
Hospital Santa Engracia-CIMA
🇲🇽
Garza Garcia, Mexico
OCA-MIRC
🇲🇽
Monterrey, Mexico
Complejo Hospitalario Nuestra Senora de Valme
🇪🇸
Sevilla, Andalucia, Spain
Railway Clinical Hospital on Donetsk Station
🇺🇦
Donetsk, UKR, Ukraine
Dniepropetrovsh State Medical Academy
🇺🇦
Dniepropetrovsk, UKR, Ukraine
Institute of Endocrinology and Metabolism
🇺🇦
Kiev, UKR, Ukraine
Hospital Clinico Pontificia Universidad Catolica de Chile
🇨🇱
Santiago, Chile
Hospital del Salvador
🇨🇱
Santiago, Chile
Klinika Endocrinologii Diabetologii I
🇵🇱
Bialystock, POL, Poland
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
🇵🇱
Lodz, Poland
NHI Kemerovo Regional Clinical Hospital
🇷🇺
Kemerovo, RUS, Russian Federation
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
🇷🇺
Moscow, RUS, Russian Federation
Central Medical Sanitary Unit #122
🇷🇺
St Petersburg, RUS, Russian Federation
TUV Medico-Military Academy
🇷🇺
St Petersburg, RUS, Russian Federation
Memphis Internal Medicine (Kathawala)
🇺🇸
Memphis, Tennessee, United States
Hospital Padre Alberto Hurtado
🇨🇱
Santiago, Region Metropolitana, Chile
Endokrinologicky ustav
🇨🇿
Praha 1, Czech Republic
Hospital Universitario Dr Jose E Gonzalez
🇲🇽
Monterrey, Nuevo Leon, Mexico
Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
🇲🇽
Mexico City, Mexico
Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
🇵🇱
Krakow, POL, Poland
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
🇷🇺
St Petersburg, RUS, Russian Federation
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
🇷🇺
St. Petersburg, RUS, Russian Federation
NHI Yaroslavl Regional Clinical Hospital
🇷🇺
Yaroslavl, RUS, Russian Federation
Bukovinian State Medical University Dept of Clinical Immun
🇺🇦
Chernivtsy, UKR, Ukraine
Centro Endocrinologic Tiempo
🇦🇷
Buenos Aires, Argentina
Diabetologicka ambulance (Chmura)
🇨🇿
Ostrava, Czech Republic
II interni klinika FN Kralovske Vinohrady
🇨🇿
Praha 10, Czech Republic
Spzital Kolejowy imm Wlodzimierza Roeflera
🇵🇱
Pruszkow, POL, Poland
NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
🇷🇺
Moscow, RUS, Russian Federation
Hospital Interzonal de Agudos Pedro Fiorito
🇦🇷
Avellaneda, Buenos Aires, Argentina
3rd Medical Department General Faculty Hospital
🇨🇿
Praha 2, Czech Republic
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
🇵🇱
Bialystok, POL, Poland
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
🇷🇺
Moscow, RUS, Russian Federation
NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
🇷🇺
Moscow, RUS, Russian Federation
Donetsk State Medical University
🇺🇦
Donetsk, UKR, Ukraine
Chase Medical Research, LLC
🇺🇸
Waterbury, Connecticut, United States
Instytut Centrum Zdrowia (009) Matki Polki
🇵🇱
Lodz, POL, Poland
MHI Clinical Hospital for Emergency Care na NV Soloviev
🇷🇺
Yaroslavl, RUS, Russian Federation
Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin)
🇺🇦
Donetsk, UKR, Ukraine
Chair Family Med of National Med University
🇺🇦
Kiev, UKR, Ukraine
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
🇷🇺
Smolensk, RUS, Russian Federation
Ukr Scientifically Practical Centre of Endocrine Surgery
🇺🇦
Kiev, UKR, Ukraine
Odessa State Medical University Dept of Gen Practice and Med Rehab
🇺🇦
Odessa, UKR, Ukraine
Odessa Reg. Clinical Hosp Outpatient Department
🇺🇦
Odessa, UKR, Ukraine
Vinnitsa State Medical University
🇺🇦
Vinnitsa, UKR, Ukraine
Outpatient Clinic of Family Physician "Rusanovka"
🇺🇦
Kiev, Ukraine
Public Institution City Policlinic #20 Odessa
🇺🇦
Odessa, Ukraine
Center for Diabetes & Endocrine Care
🇺🇸
Hollywood, Florida, United States
Clayton Medical Research
🇺🇸
St Louis, Missouri, United States
Winthrop University Hospital
🇺🇸
Mineola, New York, United States
Cedar-Crosse Research Center
🇺🇸
Chicago, Illinois, United States
John H Stoger Jr Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
Clintell Inc
🇺🇸
Skokie, Illinois, United States
Lovelace Scientific Resources (Albuquerque)
🇺🇸
Albuquerque, New Mexico, United States
Cons Asoc de Endocrinologia
🇦🇷
Buenos Aires, Argentina
Metrolina Internal Medicine
🇺🇸
Charlotte, North Carolina, United States
Sensenbrenner Primary Care
🇺🇸
Charlotte, North Carolina, United States
Collierville Medical Specialists
🇺🇸
Collierville, Tennessee, United States
GoodLife Medical Center PLLC
🇺🇸
Memphis, Tennessee, United States
Cedar Research
🇺🇸
Tacoma, Washington, United States
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
🇧🇷
Rio de Janeiro, Brazil
Hospital Italiano de Buenos Aires
🇦🇷
Buenos Aires, Argentina
CIMeL
🇦🇷
Buenos Aires, Argentina
UNIFRSP
🇧🇷
Sao Paulo, Brazil
Hospital do Rim e Hipertensao
🇧🇷
Sao Paulo, Brazil
Lifestyle Metabolism Center
🇨🇦
Toronto, Ontario, Canada
CPClin-Centro de Pesquisas Clinicas
🇧🇷
Sao Paulo, Brazil
Quest Clinical Trials
🇨🇦
Markham, Ontario, Canada
Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia
🇪🇸
Sabadell, Spain
Trial Management Group Inc (Henein
🇨🇦
Toronto, Ontario, Canada
Interní a diabetologická Outpatient
🇨🇿
Ostrava, Czech Republic
Instituto Mexicano de Investigacion
🇲🇽
Mexico City, Durango, Mexico
Instituto de Informacion de Tramiento y Educacion en Salud
🇨🇱
Santiago, Chile
Diabetologicka a interni ambulance
🇨🇿
Ostrava-Kuncice, CZE, Czech Republic
Institute for Clinical and Exp Medicine
🇨🇿
Prague 4, CZE, Czech Republic
University Hospital Na Bulovce
🇨🇿
Prague 8, CZE, Czech Republic
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
🇵🇱
Warsaw, Poland
NI Central Clinical Hospital of RAS
🇷🇺
Moscow, Russian Federation
Centrum Leczenia Chorob cywilizacyjnych
🇵🇱
Warszawa, Poland
Hospital Clinic I Provincial
🇪🇸
Barcelona, Spain
Odessa State Med Dept of Family Med and Gen Practice
🇺🇦
Odessa, UKR, Ukraine
Raidant Research-St Louis
🇺🇸
St Louis, Missouri, United States
Michigan Institute of Medicine
🇺🇸
Livonia, Michigan, United States
East Coast Clinical Research Inc
🇺🇸
Haverhill, Massachusetts, United States
Hospital Ramon y Cajal
🇪🇸
Madrid, Spain
Hospital Universitario de la Princessa
🇪🇸
Madrid, Spain
Hospital Guilherme Alvaro
🇧🇷
Santos, Brazil
Providence Health Partners - Center of Clinical Research
🇺🇸
Dayton, Ohio, United States
Radiant Research-Birmingham
🇺🇸
Birmingham, Alabama, United States
Parkway Medical Center
🇺🇸
Birmingham, Alabama, United States
Redpoint Research
🇺🇸
Phoenix, Arizona, United States
Arizona Center for Clinical Research
🇺🇸
Phoenix, Arizona, United States
National Jewish Medical & Research Center
🇺🇸
Denver, Colorado, United States
Creekside Endocrine Associates
🇺🇸
Denver, Colorado, United States
Jennifer Hone MD
🇺🇸
Denver, Colorado, United States
International Research Associates LLC
🇺🇸
Miami, Florida, United States
Wayne State University
🇺🇸
Detroit, Michigan, United States
Creighton Diabetes Center
🇺🇸
Omaha, Nebraska, United States
Duke Medical Center
🇺🇸
Durham, North Carolina, United States
Quality Assurance Research Center Inc
🇺🇸
San Antonio, Texas, United States
Clinical Trials of Texas Inc
🇺🇸
San Antonio, Texas, United States
Covenant Clinic Research
🇺🇸
San Antonio, Texas, United States
Diabetes & Glandular Disease Research Assoc PA
🇺🇸
San Antonio, Texas, United States
SAM Clinical Research Center
🇺🇸
San Antonio, Texas, United States
Charlotte Clinical Research Inc
🇺🇸
Charlotte, North Carolina, United States
Upstate Pharmaceutical Research
🇺🇸
Greenville, South Carolina, United States
Hospital de Clinicas de Porto Alegre
🇧🇷
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS
🇧🇷
Porto Alegre, Rio Grande do Sul, Brazil
Radiant Research
🇺🇸
Portland, Oregon, United States